Clinical Trial Coordinator

• Assist in coordinating and administering clinical studies from start-up to execution and close-out
• Collect, prepare, review and track documents for study applications and submissions
• Support timely submission of documents to EC/IRB and Regulatory Authorities where appropriate
• Serve as the local administrative main contact throughout the study
• Set up and maintain local eTMF and ISF, including document tracking
• Upload essential documents to maintain inspection readiness
• Prepare study documents for final archiving and support ISF close-out activities
• Produce and maintain study documents while ensuring template and version compliance
• Create and import clinical-regulatory documents into global electronic management systems
• Support electronic applications and submissions using required technical standards
• Set up and maintain study information in CTMS, SharePoint and related tracking tools
• Prepare or support site-level contracts and HCO/HCP payments
• Manage and track study materials and equipment
• Coordinate administrative tasks during studies, audits and regulatory inspections
• Lead practical arrangements for internal and external meetings
• Prepare and distribute presentation materials, newsletters, websites, letters and meeting minutes
• Handle and archive study- and country-related emails
• Facilitate delivery of study documents and materials with data management teams
• Ensure compliance with company policies, safety requirements and applicable legislation

• Coordinates and administers clinical studies from start-up through execution and close-out
• Supports EC/IRB and, where appropriate, Regulatory Authority submissions
• Interfaces with Investigators, external service providers, CRAs, LSAD, Data Management Centre and Global Clinical Solutions representatives
• Maintains local eTMF and ISF in accordance with ICH-GCP and local requirements
• Ensures essential documents are uploaded promptly for eTMF inspection readiness
• Creates/imports clinical-regulatory documents into electronic management systems such as ANGEL
• Handles documents according to Submission Ready Standards (SRS)
• Uses client tracking and communication tools such as CTMS and SharePoint
• Supports site-level contract preparation and HCO/HCP payments in accordance with local regulations
• Coordinates study materials and equipment
• Supports audits, regulatory inspections, meetings, newsletters, websites, document distribution and archiving
• Performs layout and language control, copying, distribution, local translation and spell checks in English and the local language as required
• Ensures compliance with ICH-GCP, client Code of Ethics, company SOPs, and applicable local, national and regional legislation
• Location preference: Hanoi, Vietnam

• Fully remote work mode
• Standard Monday–Friday work schedule